TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB

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ClinicalTrials.gov Identifier: NCT00023348

Recruitment Status : Completed

First Posted : September 10, 2001

Last Update Posted : September 13, 2005

Sponsor:

Collaborator:

VA Office of Research and Development

Information provided by:

Centers for Disease Control and Prevention

Study Description

Brief Summary:

Primary Objectives:

1) To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetic parameters for isoniazid and rifabutin.

Secondary Objectives:

To determine risk factors for abnormal pharmacokinetic parameters for isoniazid and rifabutin.
To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy.
To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy.
To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.

Condition or disease	Intervention/treatment	Phase
HIV Infections Tuberculosis	Drug: Isoniazid Drug: Rifabutin	Phase 2 Phase 3

Detailed Description:

This study will seek to enroll every eligible patient enrolled in TBTC Study 23. Consenting patients will be asked to undergo measurements of isoniazid (if receiving), rifabutin and 25-OH desacetyl rifabutin levels at a time point in the study when steady state rifabutin levels are expected to have been achieved (at least two weeks following the start of rifabutin).

Study Design


Study Type :	Interventional (Clinical Trial)
Enrollment :	150 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in USPHS Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
Study Start Date :	July 1999
Study Completion Date :	November 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Tuberculosis

Drug Information available for: Isoniazid Rifabutin

Genetic and Rare Diseases Information Center resources: Tuberculosis

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetics of isoniazid and rifabutin.

Secondary Outcome Measures :

1) To determine risk factors for abnormal pharmacokinetics of isoniazid and rifabutin
2) To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy.
3) To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy.
4) To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Patient enrolled in TBTC Study 23
Informed consent

Exclusion:

1. Severe anemia (Hct <25%)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00023348

Show 23 Study Locations

Sponsors and Collaborators

Centers for Disease Control and Prevention

VA Office of Research and Development

Investigators


Principal Investigator:	Marc Weiner, MD	Audie L. Murphy VA Medical Center, San Antonio TX

More Information

Additional Information:

(Click here for more information about the Tuberculosis Trials Consortium (TBTC) This link exits the ClinicalTrials.gov site

Publications of Results:

Weiner M, Benator D, Burman W, Peloquin CA, Khan A, Vernon A, Jones B, Silva-Trigo C, Zhao Z, Hodge T; Tuberculosis Trials Consortium. Association between acquired rifamycin resistance and the pharmacokinetics of rifabutin and isoniazid among patients with HIV and tuberculosis. Clin Infect Dis. 2005 May 15;40(10):1481-91. Epub 2005 Apr 14.


ClinicalTrials.gov Identifier:	NCT00023348 History of Changes
Other Study ID Numbers:	CDC-NCHSTP-2173 23A
First Posted:	September 10, 2001 Key Record Dates
Last Update Posted:	September 13, 2005
Last Verified:	September 2005

Keywords provided by Centers for Disease Control and Prevention:


Tuberculosis TB

Additional relevant MeSH terms:


HIV Infections Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections	Bacterial Infections Isoniazid Rifabutin Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Antibiotics, Antitubercular

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